Veteran Social Support for Smoking Cessation

(VAntage Trial)

Overseen By Alicia B Woodward-Abel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Cessation medications

Disqualifiers: No phone contact, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

2376 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans quit smoking by examining the role of social support in the process. Veterans in the study will select a support person to assist them, either immediately or when they feel ready to quit. The trial will explore various levels of support, including coaching calls and written materials. Veterans who have smoked at least one cigarette in the past month and have a supportive adult contact are ideal candidates. As an unphased trial, this study offers Veterans a unique opportunity to explore personalized support strategies for quitting smoking.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have used cessation medications or a stop smoking program in the past 3 months, you are not eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that social support can help people quit smoking. Studies have found that individuals trying to quit are more likely to use quitlines, phone support services, when they have a support person who receives coaching calls. This method has been linked to higher success rates in quitting.

Regarding safety, having a support person or receiving coaching calls poses no major risk. Most people find these methods easy to handle. The process involves discussing strategies and receiving advice, which is safe for most individuals.

Written materials are also a safe part of this study. They provide information and tips on quitting smoking, serving as a helpful resource without safety concerns. Overall, both coaching calls and written materials are considered safe and supportive ways to help people quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to help veterans quit smoking by focusing on social support. Unlike typical smoking cessation methods that often rely on medications or solo counseling, this approach emphasizes the role of a support person. The unique element here is the combination of written materials and a personalized coaching call for the supporter, aiming to empower them with strategies to assist the veteran. This method could enhance the quitting process by creating a supportive environment, potentially increasing success rates through community and connection, rather than just focusing on the individual smoker.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

In this trial, participants in the "Support Person Coaching Call and Written Materials" arm will have their support persons receive coaching calls. Research has shown that coaching calls for support persons can help smokers quit by encouraging greater use of quitline services. One study found that when support persons received phone coaching, more smokers enrolled in quitline programs. Another study discovered that those who received coaching were more likely to obtain prescriptions to aid in quitting smoking compared to those without coaching. These findings suggest that coaching calls for support persons effectively help smokers seek assistance and make progress in quitting. ^{2 4 6 7 8}

Who Is on the Research Team?

Steven S. Fu, MD MSCE

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

This trial is for Veterans who smoke cigarettes and have a support person willing to help them quit. The Veteran must be using cigarettes primarily if they use other tobacco products, and should have smoked at least once in the past month. Their chosen support person needs to be an adult they're in contact with at least three times a week.

Inclusion Criteria

Veteran must have smoked at least 1 cigarette over the past 30 days, even a puff

If using other tobacco or nicotine products, cigarettes must be the main product used

Must be able to identify one adult family member or friend with whom they have contact at least 3 times per week who will enroll as the Veteran Support Person

Exclusion Criteria

Veteran must have used cessation medications or a stop smoking program within the past 3 months

I have a working phone number.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive written materials and, for the intervention group, a 1-call coaching session to support smoking cessation

6 months

1 call (15-25 minutes) for intervention group

Follow-up

Participants are monitored for smoking abstinence and use of cessation treatments

6 months

Assessments at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• SP written materials
• Support Person Coaching Call
• Written Smoking Cessation Materials

Trial Overview The study tests whether having a support person receiving coaching calls and written materials can enhance smoking cessation efforts among Veterans. It aims to determine how social support affects the quitting process, potentially leading to new tailored cessation strategies.

How Is the Trial Designed?

Group I: Support Person Coaching Call and Written Materials Experimental Treatment 3 Interventions

Support persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Support person participants assigned to the intervention group will additionally receive a 1-call coaching session about 15-25 minutes in duration on how to support their Veteran smoker. The coaching session will be delivered by research staff by phone or video call. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options.

Group II: Written Materials Only Active Control 2 Interventions

Support persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Smoking-cessation campaigns using printed self-help materials can lead to abstinence rates of up to 20% after 12 months, highlighting their potential effectiveness.

While personalized materials do not improve cessation rates, incorporating social support and minimal personal contact can enhance the likelihood of quitting, indicating the importance of community and support in smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-help smoking cessation materials. Brown, SL., Owen, N.[2019]

An intervention designed for nonsmoking support persons to encourage smokers to use the QUITPLAN Helpline was developed and piloted, showing high compliance with 93% of support people completing all sessions.

The intervention was well-received, with 77% of support persons finding it helpful, and it successfully led to five smokers calling the helpline, indicating its potential effectiveness in promoting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support person intervention to promote smoker utilization of the QUITPLAN Helpline. Patten, CA., Smith, CM., Brockman, TA., et al.[2022]

Every smoker should be offered smoking cessation treatment at every healthcare visit, as even brief interventions can be effective in helping individuals quit smoking.

The most effective smoking cessation strategies include nicotine replacement therapy, clinician-delivered social support, and skills training, with more intensive treatments leading to better long-term success in quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation: information for specialists. Agency for Health Care Policy and Research. [2015]

A study analyzing the Partner Interaction Questionnaire (PIQ) responses from smokers in a cessation program identified four distinct factors of social support, which were more effective in predicting smoking cessation than the traditional two-factor model.

Using a more detailed approach to measure social support can enhance our understanding of its role in helping individuals quit smoking, suggesting that tailored support strategies may be more beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relation between social support and smoking cessation: revisiting an established measure to improve prediction. Burns, RJ., Rothman, AJ., Fu, SS., et al.[2021]

The pilot study successfully recruited 30 support person-smoker dyads from diverse, low-income communities, indicating that outreach methods were effective, particularly in-person recruitment.

While the intervention was generally well-received by support persons, only 7% of smokers utilized quitline services, and only 13% achieved biochemically verified smoking abstinence at 3 months, suggesting that further adaptations are necessary to improve engagement and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support person interventions to increase use of quitline services among racially diverse low-income smokers: A pilot study. Patten, CA., Fu, S., Vickerman, K., et al.[2023]

The study highlights the effectiveness of a 15-30 minute phone intervention delivered by tobacco cessation coaches, aimed at helping family members support smokers in quitting, based on analysis of 193 recorded sessions.

Key barriers faced by support persons, such as uncertainty in how to approach the smoker and the smoker's readiness to quit, were identified, along with coaches' strategies to address these challenges, providing valuable insights for clinicians and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skill Sets for Family Members and Friends to Help Motivate a Smoker to Seek Treatment: Research to Practice. Brockman, TA., Patten, CA., Lukowski, A.[2020]

A pilot study at Georgetown University showed that a 6-hour training program for advanced practice nursing students significantly improved their knowledge and confidence in helping patients quit tobacco.

The 'Rx for Change' curriculum demonstrates the importance of targeted training for healthcare providers to effectively support tobacco cessation efforts among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Rx for Change tobacco curriculum in advanced practice nursing education. Kelley, FJ., Heath, J., Crowell, N.[2019]

In a study involving 231 outpatients, staff-initiated telephone interviews effectively captured reliable reports of new or unusual symptoms after patients were prescribed medications, demonstrating the potential of this method for monitoring adverse drug reactions (ADRs).

The approach successfully identified known ADRs associated with tricyclic antidepressants and antibiotics, suggesting that structured follow-up can enhance postmarketing surveillance of drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New approaches to postmarketing surveillance. Fisher, S., Bryant, SG., Kluge, RM.[2019]

This systematic review aims to evaluate the clinical efficacy and safety of Chinese herbal medicine (CHM) compared to placebo in treating stable chronic obstructive pulmonary disease (COPD), using data from multiple databases and including randomized controlled trials.

The primary outcomes will focus on quality of life, symptom scores, and exacerbation frequency, while secondary outcomes will assess lung function and adverse events, providing a comprehensive evaluation of CHM's effectiveness and safety for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese Herbal Medicine Versus Placebo for the Treatment Of Chronic Obstructive Pulmonary Disease: A Protocol of Systematic Review and Meta-analysis. Xiong, C., Li, Y., Zeng, Y., et al.[2023]

An empathic and personalized smoking cessation intervention program, with extended assistance and follow-up, is the most effective way to prevent serious health issues like heart disease and cancer in tobacco users, aiming for complete cessation rather than just reduction.

Current guidelines for smoking cessation, based on the Transtheoretical Model and the 'Five A's' (Ask, Advise, Assess, Assist, Arrange), provide a structured approach for clinicians, but these interventions are often underutilized due to a lack of training and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco cessation in primary care: maximizing intervention strategies. Anczak, JD., Nogler, RA.[2022]

Over 12% of the U.S. population uses herbal therapies annually, leading to significant out-of-pocket expenses, particularly among patients with chronic diseases, highlighting the need for better education among healthcare providers regarding the safety of these therapies.

There is a pressing need for improved post-market surveillance of dietary supplements to monitor safety, identify harmful products, and study their mechanisms of action, as current research has primarily focused on efficacy rather than safety, leading to potential risks for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assurances for dietary supplements policy issues and new research paradigms. Basch, EM., Servoss, JC., Tedrow, UB.[2008]

A pilot study involving 1021 users of ibuprofen from community pharmacies in Scotland and England revealed a significant increase in gastrointestinal symptoms after use, highlighting potential safety concerns with non-prescription medications.

The study suggests that community pharmacies could play a crucial role in monitoring adverse events related to non-prescription medicines, indicating a need for improved pharmacovigilance practices to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK. Layton, D., Sinclair, HK., Bond, CM., et al.[2015]

The study analyzed adverse event reports related to herbal supplements from two databases, FAERS and CVAR, revealing that herbal supplements accounted for 2.51% and 6.83% of total reports, respectively, indicating a significant presence of herbal-related safety concerns.

Common herbs associated with adverse events included Avena sativa (oats), Cannabis sativa (marijuana), and Hypericum perforatum (St John's Wort), highlighting the need for further investigation into the safety profiles of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. Sharma, V., Gelin, LFF., Sarkar, IN.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6542743/

Support person interventions to increase use of quitline ... But the study had some feasibility challenges (e.g., SP coaching call completion: 60% and SP study retention: 53%). At 3 months, 2 smokers (7%) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211335525003201

Social support intervention for enhancing smoking ... Prior studies have found that having a support person who received coaching calls increased use of quitlines (Patten et al., 2017). We conducted ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5914310/

Linking smokers to a quitline: randomized controlled ... A three-session phone intervention for nonsmoking family members and friends (ie support persons) was successful for increasing smoker quitline enrollment.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025003529

Effectiveness of family-based behavioral intervention for ... Family-based behavioral interventions include a comprehensive approach to support smoking cessation, which includes offering brief advice to ...

5. stacks.cdc.gov stacks.cdc.gov/view/cdc/42734/cdc_42734_DS1.pdf

Telephone-Based Coaching: A Comparison of Tobacco ... Coaching participants and class attendees filled tobacco-cessation prescriptions at a higher rate (47% for both) than matched controls (6%, P<0.001).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6128961/

Feasibility of a support person intervention to promote ... Social support may be an effective strategy to increase engagement in cessation treatment for smokers with mental illness.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5118192/

Telephone-Based Coaching: A Comparison of Tobacco ... Telephonic wellness coaching was as effective as in-person classes and was associated with higher rates of quitting compared to no treatment. The telephonic ...

8. hhs.gov hhs.gov/sites/default/files/hhs-framework-support-accelerate-smoking-cessation-2024.pdf

HHS Framework to Support and Accelerate Smoking ... Strengthen, Expand, and Sustain Cessation Services and Supports. To help people quit smoking, it is important to have strong cessation supports in place with.